Often, because of ear infections and other ear problems, hearing can become impaired. It is common practice in the treatment of retracted tympanic membranes, serious otitis media, Eustachian tube malfunction and other middle ear problems to provide a small passageway in the tympanic membrane, which is commonly referred to as the eardrum. The passageway provides fluid communication between the middle ear cavity and outer ear cavity such that negative pressure can be relieved (i.e., to equalize pressure), so that excess fluid can be drained, and so that medicine can be injected into the middle ear cavity.
In the past, ear, or tympanotomy, tubes have been inserted into the passageway so that it does not heal (e.g., close) too quickly. Tubes generally have included enclosed lumens that provide fluid (e.g., gaseous and liquid) communication between the middle and outer ear cavities. More recently, there has been a demand for ear vent devices that provide a better anatomical fit within the tympanic membrane, are easier to insert and remove, and cause less trauma to the eardrum during insertion, during removal, and while in place.
Some prior implants, such as illustrated in U.S. Pat. No. 4,744,792 (Sander, et al.), are configured to have a generally elongated cylindrical shape with an enclosed lumen therein. Flanges typically being disc shaped are provided at the oppositely disposed ends of the tube such that the device resembles a spool or bobbin. The flanges assist to hold the tube in place in the surgically formed passageway in the tympanic membrane.
Other prior implant devices, such as illustrated in U.S. Pat. No. 4,675,085 (Tretbar), are generally T-shaped and are commonly referred to as T-tubes. The T-tube comprises a crossbar which can assist to hold the tube in place in the surgically formed passageway in the tympanic membrane. Moreover, the crossbar can assist to direct fluid(s) to the tube having an enclosed or internal lumen. The tube is passed through the membrane.
In many instances, however, when the incision is made longer or has to be L-shaped so that the tube and its flanges can be inserted into the tympanic membrane, the process for making the incision can further traumatize the eardrum. When the trauma will be too much for the patient to handle under a local anesthetic, the procedure to insert the tube will likely need to be performed in an operating room at the hospital with the patient being anesthetized with a general anesthetic. Such a procedure with a general anesthetic at the hospital is more costly and takes additional time for the patient due to increased preparation time for and recovery time from the general anesthetic and the additional trauma to the eardrum.
The incision made in the tympanic membrane, with fibers extending inwardly in a spoke-like fashion, provides a generally triangular shaped passageway or slit to receive the tube. Tubes for insertion into the tympanic membrane typically have a circular cross section (e.g., bobbin shaped tube) and/or an oversized flange (e.g., T-shaped tube), and thus traumatize the eardrum due to the dramatic geometric misfit between the tube and the opening. Moreover, the likelihood of extrusion of the tube from the tympanic membrane is further increased as well due to the geometric misfit. This geometric misfit is believed to result in scaring of the tympanic membrane once the tube is removed. Moreover, tubes with non-collapsible flanges will further traumatize the eardrum as the tube is removed or otherwise extruded from the eardrum.
Currently available tubes with a circular cross section have flanges at the end that extend around the entire periphery of the tube opening so as to provide a disc shaped flange to anchor and stabilize the ear tube in the tympanic membrane so that the tube is supported and secured therein, and so that the tube is not easily extruded. In many instances, however, the flanges, especially when wide or oversized, can traumatize the tympanic membrane over time. This trauma to the tympanic membrane can limit the time period in which the ear tube can remain in the tympanic membrane. Consequently, in some instances, the ear tube has to be removed to limit additional trauma to the eardrum. This can result in the need to repeat the procedure for providing a passageway between the middle and outer ear cavities and inserting a tube therein.
As can be seen, currently available implants have a number of shortcomings that can greatly reduce the ability of the implant to remain in the tympanic membrane and perform their intended function. The current structures and assemblies provide an implant that can damage or traumatize the recipient site area in the tympanic membrane, which in turn, can hamper or interfere with an implant's ability to assist in healing the eardrum. In addition, the trauma inflicted by the implant can weaken the eardrum and can contribute to further complications. Moreover, some implants are not easily inserted into the slit or passageway in the tympanic membrane. A need currently exists in the ear tube industry for an implant that is more easily inserted into or through the tympanic membrane, and is configured to minimize further trauma to the ear and the tympanic membrane.